20

Aug

2003

Inc Class II Alcon Laboratories

0

Company: Alcon Laboratories, Inc
Date of Enforcement Report: 8/20/03
Class: II

PRODUCT
“Alcon Ladarwave Custom Cornea Wavefront System” Aberrometer software Version 7.91. Recall # Z-1078-03.

REASON
Software error could, under specific circumstances, allow the patient’s centration images and data to be stored incorrectly.

CODE
Serial Numbers: LWN1002Z LWN1003Z LWN1010Z LWN1011Z LWN1013Z LWN1023Z LWN1025Z LWN1035Z LWN1040Z LWN1440Z LWN1513Z LWN1522Z LWN1626Z LWN1629Z LWN1647Z LWN1748Z LWN1796Z LWN1805Z LWN1817Z LWN1820Z LWN1821Z LWN1822Z LWN1823Z LWN1843Z LWN1846Z LWN1944Z LWN1945Z LWN1946Z LWN1947Z LWN1949Z LWN1950Z LWN1952Z LWN1953Z LWN1954Z LWN1955Z LWN1956Z LWN1957Z LWN1958Z LWN1959Z LWN1961Z LWN2187Z LWN2188Z LWN2189Z LWN2190Z LWN2191Z LWN2192Z LWN2193Z LWN2194Z LWN2197Z LWN2198Z LWN2199Z LWN2200Z LWN2262Z LWN2263Z LWN2264Z LWN2265Z LWN2267Z LWN2268Z LWN2269Z LWN2270Z LWN2271Z LWN2272Z LWN2273Z LWN2276Z LWN2277Z LWN2278Z LWN2279Z LWN2280Z LWN2342Z LWN2343Z LWN2344Z LWN2345Z LWN2346Z LWN2347Z LWN2348Z LWN2349Z LWN2350Z LWN2351Z LWN2352Z LWN2353Z LWN2355Z LWN2356Z LWN2357Z LWN2403S LWN2404S LWN2405S LWN2406S LWN2414Z LWN2415Z LWN2416Z LWN2417Z LWN2420Z LWN2421Z LWN2427S LWN2428S LWN2464Z LWN2465Z LWN2466Z LWN2467Z LWN2468Z LWN2469Z LWN2470Z LWN2471Z LWN2472Z LWN2473Z LWN2475Z LWN2476Z LWN2477Z LWN2478Z LWN1609Z LWN1951Z.

RECALLING FIRM/MANUFACTURER
Alcon Laboratories, Inc., Orlando, FL, by letters on July 21, 2003. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
157.

DISTRIBUTION
Nationwide

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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